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Prevention study for Sedation and Analgesia Monitoring
Official title Prevention of Organ Dysfunction and Mortality by Monitoring the Administration of Opioids and Hypnotics in Patients at High Postoperative Risk
ClinicalTrials.gov ID: NCT05893030
What this study is testing
- What it's testing
- Intraoperative hypotension is a common situation. It increases postoperative morbidity and mortality, especially in patients at high postoperative risk undergoing high-risk surgery.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- patients affiliated to the French Social Security;
- informed and signed consent to participating in the study;
- planned postoperative hospitalization \> 48 hours;
- patients over 75 years of age with at least one of the following postoperative risk factors:
- ischemic coronary disease;
See the full eligibility criteria
- patients affiliated to the French Social Security;
- informed and signed consent to participating in the study;
- planned postoperative hospitalization \> 48 hours;
- patients over 75 years of age with at least one of the following postoperative risk factors:
- ischemic coronary disease;
- history of compensated or prior heart failure;
- stroke;
- significant arrhythmias: fibrillation or auricular flutter with ventricular response \> 100/minute, multiform QRS complex) or cardiac conduction abnormalities (trifascicular block, auriculoventricular block of the...
- peripheral vascular disease;
- chronic obstructive pulmonary disease;
- chronic respiratory failure;
- renal insufficiency, defined by a creatinine \> 175 µmol.l-1 (2 mg.dl-1);
- insulin therapy for diabetes;
- active cancer;
- chronic alcohol abuse;
- dementia.
- elective or emergency high-risk surgery under general anesthesia with a combination of hypnotic and opioid, and intubation or placement of a supraglottic airway control device Non
- Patients who meet one or more of the preoperative following criteria will not be included:
- acute heart failure or acute myocardial infarction;
- complete arrhythmia due to atrial fibrillation;
- acute respiratory failure or pneumonia;
- septic shock;
- acute stroke;
- cardiac surgery;
- open chest surgery;
- opioid free anesthesia;
- intraoperative ketamine at a dose \> 0.25 mg.kg-1; \> 0.25 mg/kg or or intravenous electric syringe
- lidocaine or dexmedetomidine by continuous infusion;
- refusal to participate in the study;
- patient under guardianship, conservatorship, or unable to understand the study.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Besançon, France
- Bordeaux, France
- Clermont-Ferrand, France
- Grenoble, France
- Lille, France
- Marseille, France
- Nantes, France
- Nîmes, France
- Paris, France
- Pierre-Bénite, France
- Poitiers, France
- Saint-Dié, France
- Saint-Etienne, France
- Toulouse, France
- Villejuif, France
- Villeurbanne, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Besançon, France; Bordeaux, France; Clermont-Ferrand, France; Grenoble, France; Lille, France and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.